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FDA 510(k)

BonOs Inject, Pedicle screw kits, Cement pusher

K-Number: K202458 · 2021-05-18

ApplicantOsartis GmbH
Decision Date2021-05-18
Product CodeLOD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BonOs Inject, Pedicle screw kits, Cement pusher is a medical device manufactured by Osartis GmbH. It received FDA 510(k) clearance on 2021-05-18 under approval number K202458. The device is classified under product code LOD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BonOs Inject, Pedicle screw kits, Cement pusher?

BonOs Inject, Pedicle screw kits, Cement pusher is a medical device that received FDA 510(k) clearance on 2021-05-18. It is manufactured by Osartis GmbH. The 510(k) number is K202458.

When was BonOs Inject, Pedicle screw kits, Cement pusher approved by the FDA?

BonOs Inject, Pedicle screw kits, Cement pusher received FDA 510(k) clearance on 2021-05-18, under approval number K202458.

What company makes BonOs Inject, Pedicle screw kits, Cement pusher?

BonOs Inject, Pedicle screw kits, Cement pusher is manufactured by Osartis GmbH.

What is the FDA product code for BonOs Inject, Pedicle screw kits, Cement pusher?

The FDA product code for BonOs Inject, Pedicle screw kits, Cement pusher is LOD.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05565131 Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System for Intra-pedicular Screw Placement in Adult Spine Surgery COMPLETED NCT06960018 Clinical Study on the Safety and Efficacy of the Minimally Invasive Ennovate® Method for Pedicle Screw Placement RECRUITING NCT07408726 Monoaxial vs. Polyaxial Percutaneous Hybrid Stabilization NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41487949 Verification, validation, and uncertainty quantification of finite element analysis results for pedicle screw assemblies under ASTM F1717 flexion and extension testing. Frontiers in bioengineering and biotechnology (2025)

Other Devices by Osartis GmbH

K192394Hi-Fatigue Bone Cement K192379Hi-Fatigue G Bone Cement K210120BonOs HV, BonOs MV, BonOs LV K210125BonOs HV Genta, BonOs MV Genta, BonOs LV Genta K240856Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds

Related Devices (Code: LOD)

K153737OSTEOPAL plusHeraeus Medical GmbH K172408Biomet Bone Cement RBiomet, Inc. K170802TRAUMACEM™ V+ Injectable Bone CementSynthes (USA) Products, LLC K171540Refobacin Bone Cement RBiomet, Inc. K182260PALACOS MVHeraeus Medical GmbH K173494OrthoSteady G Bone CementG21, S.R.L.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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